# K243217: Legend X Desktop System

- Pathway: 510(k) (Traditional)
- Applicant: Pollogen, Ltd.
- Decided: Nov 1, 2024 after 29 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K232903 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232903: Legend X Platform, Pollogen, Ltd. (2023) Summary page 5.

## Indications for use
The Legend X Desktop System and its accessories are intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO). It is also intended for use in dermatologic and general surgical procedures for non-invasive treatment when using RF Energy and for muscle conditioning to stimulate healthy muscles (TriPollar Applicator). Legend X Desktop System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. Legend X Desktop System is intended to be operated by a licensed health care practitioner who is present to monitor treatment.

Source page: https://510kreport.com/device/K243217
Methodology: https://510kreport.com/methodology